HyperlipidemiaNCT07546162
Development and Clinical Validation of Key Technologies for Non-invasive Breath Metabolic Fingerprinting for Large-scale Population Lipid Screening
An observational study of Hyperlipidemia, run by Beijing Anzhen Hospital.
Trial summary
This study collects exhaled breath condensate samples from healthy populations and hyperlipidemic populations, analyzes the characteristics of the exhaled metabolic lipid profile for early identification of people with abnormal blood lipids, verifies the feasibility and accuracy of a new gas detection method for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Lipid Abnormality Mass Spectrometry Screening Model
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- 14 Sep 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy population, population with hyperlipidemia
Who may be able to join
- Age ≥ 18 years
- Voluntarily sign the informed consent form
Who cannot join
- Patients with lung cancer, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or acute respiratory distress syndrome
- Women during pregnancy or breastfeeding
- Patients with chronic kidney disease (GFR <60 ml/min) or liver cirrhosis
- Individuals unable to cooperate in collecting exhaled breath samples
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study collects exhaled breath condensate samples from healthy populations and hyperlipidemic populations, analyzes the characteristics of the exhaled metabolic lipid profile for early identification of people with abnormal blood lipids, verifies the feasibility and accuracy of a new gas detection method for screening abnormal blood lipids, and explores a simple, fast, and non-invasive method for screening abnormal blood lipids.
- Conditions
- Hyperlipidemia
- Being tested
- Lipid Abnormality Mass Spectrometry Screening Model
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipid Abnormality Mass Spectrometry Screening ModelDiagnostic test
By analyzing the lipid profile in human breath, explore a simple, fast, and non-invasive method for screening dyslipidemia
| Study group | Role | What they receive |
|---|---|---|
| Hyperlipidemia | Not described Receives: Diagnostic Test: Lipid Abnormality Mass Spectrometry Screening Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity , specificity , Receiver Operating Characteristic Curve and Area Under Curve of mass spectrometry screening model for dyslipidemia
Measured: Week1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start14 Sep 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546162
- Sponsor's protocol ID
- KS2025237
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Validation of Key Technologies for Non-invasive Breath Metabolic Fingerprinting for Large-scale Population Lipid Screening
- ClinicalTrials.gov ID
- NCT07546162
- Acronym / sponsor ID
- KS2025237
- Conditions
- Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 14 Sep 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study collects exhaled breath condensate samples from healthy populations and hyperlipidemic populations, analyzes the characteristics of the exhaled metabolic lipid profile for early identification of people with abnormal blood lipids, verifies the feasibility and accuracy of a new gas detection method for screening abnormal blood lipids, and explores a simple, fast, and non-invasive method for screening abnormal blood lipids.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hyperlipidemia | – | Diagnostic Test: Lipid Abnormality Mass Spectrometry Screening Model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy population, population with hyperlipidemia
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Voluntarily sign the informed consent form
Key exclusion criteria (4 listed)
- Patients with lung cancer, asthma, chronic obstructive pulmonary disease, cystic fibrosis, or acute respiratory distress syndrome
- Women during pregnancy or breastfeeding
- Patients with chronic kidney disease (GFR <60 ml/min) or liver cirrhosis
- Individuals unable to cooperate in collecting exhaled breath samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lipid Abnormality Mass Spectrometry Screening ModelBy analyzing the lipid profile in human breath, explore a simple, fast, and non-invasive method for screening dyslipidemia | Diagnostic test | Hyperlipidemia |
Primary outcome
Sensitivity , specificity , Receiver Operating Characteristic Curve and Area Under Curve of mass spectrometry screening model for dyslipidemia
Time frame: Week1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, run by Beijing Anzhen Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Yan (+861064456782, eva3321@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity , specificity , Receiver Operating Characteristic Curve and Area Under Curve of mass spectrometry screening model for dyslipidemia (time frame: Week1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.